The planned changes focus on the following areas: rigor and transparency in research, vertebrate animals, inclusion reporting, data safety monitoring, research training, appendices, font requirements, and biosketch clarifications.
Phase 1: Effective for NIH/AHRQ applications submitted for due dates on or after January 25, 2016.
- Use of a new “Authentication of Key Biological and/or Chemical Resources” attachment (uploaded in Other Attachments section of R&R Other Project Information form)
- Vertebrate Animals (applies to NIH but not AHRQ)
- Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
- A description of veterinary care is no longer required
- Justification for the number of animals has been eliminated
- A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals
- Definition of “child” (applies to NIH but not AHRQ) The age of a “child” for the purposes of NIH’s inclusion policy will apply to individuals who are 18 years old instead of under 21 years old.
- Updated requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form:
- “Recruitment and Retention Plan to Enhance Diversity” - applicants will be asked to focus on recruitment
- “Human Subjects” - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
- “Vertebrate Animals” - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
- “Progress Report” - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process
More information on this phase will be provided in 2016.
See NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (NOT-OD-16-004) for additional details.
In a related notice, NIH & AHRQ Announce Upcoming Changes to Post-Award Forms and Instructions (NOT-OD-16-005), NIH and AHRQ plan to change policies, forms, and instructions for interim and final progress reports, and other post-award documents associated the monitoring, oversight, and closeout of an award. This also applies to revised Ruth L. Kirschstein National Research Service Award (NRSA) forms.
- Changes to Research Performance Progress Reports (RPPR)
- As of 12/1/2015: New training data tables. See NOT-OD-15-112 and NOT-OD-16-007.
- As of 1/22/2016: Updates Coming to the Screens in the Inclusion Management System (IMS). More information will be posted in a separate Guide Notice just prior to when the changes will be implemented.
- As of 1/25/2016: Addition of clarifying rigor language. See NOT-OD-16-011 and NOT-OD-15-012.
- Changes to the following forms also are anticipated:
- PHS 2271— Statement of Appointment—as of 1/22/2016
- PHS 416-7— NRSA Termination Notice—as of 1/22/2016
- PHS 2590— Noncompeting Continuation Progress Report—as of 3/25/2016
- Final Progress Report Instructions—as of 3/25/2016